Reducing HIV Risk Among Pregnant Women in Drug Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00332813
First received: June 1, 2006
Last updated: March 26, 2013
Last verified: January 2006
  Purpose

We propose to develop and pilot test an intervention that addresses both sex- and drug-related HIV risk behavior among pregnant women in drug treatment. In the first phase of the study, we will conduct focus groups with pregnant women in drug treatment, as well as a focus group with their treatment providers, in order to determine key areas of emphasis for an intervention in this population. We will then develop an HIV risk behavior intervention for pregnant women in drug treatment, pilot the intervention with 20 women, and elicit their feedback regarding the intervention. Following refinement of the intervention, we will conduct a small randomized trial (n=60) to examine the impact of the intervention compared to standard care (SC). We expect that, relative to SC, participants randomized to the intervention condition will have lower levels of sex- and drug-related HIV risk behavior.


Condition Intervention Phase
HIV Risk Behavior
Behavioral: HIV Risk Behavior Intervention
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing HIV Risk Among Pregnant Women in Drug Treatment

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Unprotected vaginal or anal intercourse
  • Sharing of injection drug works

Secondary Outcome Measures:
  • Risk Assessment Battery

Estimated Enrollment: 98
Study Start Date: February 2006
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

HIV is a critical and costly health problem for American women. Among pregnant drug abusers, sex- and drug-related HIV risk behavior occur at alarming rates. While motivationally-enhanced HIV risk behavior interventions have demonstrated efficacy with similar populations, very little work has been directed toward pregnant women in drug abuse treatment. The long-term objective of this research program is to reduce HIV risk behavior among pregnant women engaged in drug abuse treatment by developing and establishing the efficacy of an intervention that combines motivational interviewing, psychoeducation, and skill building exercises. Furthermore, we seek to advance knowledge of the mechanism of action by which interventions reduce HIV risk behavior. In the present application, we propose to develop and pilot test an intervention that addresses both sex- and drug-related HIV risk behavior among pregnant women in drug treatment. In the first phase of the study, we will conduct focus groups with pregnant women in drug treatment, as well as a focus group with their treatment providers, in order to determine key areas of emphasis for an intervention in this population. We will then develop an HIV risk behavior intervention for pregnant women in drug treatment, pilot the intervention with 20 women, and elicit their feedback regarding the intervention. Following refinement of the intervention, we will conduct a small randomized trial (n=60) to examine the efficacy of the intervention relative to standard care (SC). We expect that, relative to SC, participants randomized to the intervention condition will have lower levels of sex- and drug-related HIV risk behavior. We will also examine the potential mechanisms by which the intervention produces a reduction in HIV risk behavior. If found to be efficacious, this intervention will help to reduce the acquisition of HIV among pregnant drug abusers, improving health outcomes for the women and their children.Relevance to Public Health: The proposed study is designed to develop and test an intervention to reduce sex- and drug-related behavior that places pregnant drug abusers at risk for HIV infection. If successful, this intervention could reduce the rate of HIV infection in these women and their children.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:18 years of age or older, less than 32 weeks gestation, drug dependence (other than nicotine), have engaged in sex- or drug-related HIV risk behaviors at least monthly for 3 months prior to recruitment -

Exclusion Criteria:Currently psychotic, unable to provide names and contact information for two people who could serve as locators

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332813

Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Susan E. Ramsey, Ph.D. Brown Medical School/Rhode Island Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00332813     History of Changes
Other Study ID Numbers: DA020930, R01DA020930
Study First Received: June 1, 2006
Last Updated: March 26, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV Risk Behavior
Pregnancy
Drug Abuse

ClinicalTrials.gov processed this record on July 09, 2014